N350291

N350291 July 16, 2025 CLA-2-98:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9817.00.96 Rick Van Arnam Barnes, Richardson & Colburn, LLP 45 Broadway, Suite 3130 New York, NY 10006 RE: The eligibility under the Nairobi Protocol of a toilet lift assist from China Dear Mr. Van Arnam: In your letter dated June 16, 2025, you requested a ruling to determine the eligibility of the toilet lift under the Nairobi Protocol on behalf of SedMed, Inc. (“SedMed”). SedMed Toilet Lift Assist is described as a durable medical equipment (DME) and an FDA class I medical device. It is a non-electric, hydraulic-powdered toileting aid consisting of a steel frame, two handlebars, a release lever, an automatic locking and release mechanism, and a hydraulic gas spring with five adjustable resistance settings ranging from 75 to 275 pounds. It is said to aid individuals who are unable to use a standard toilet independently due to handicaps such as severe arthritis, multiple sclerosis, muscular dystrophy, stroke recovery, or reduced lower-body strength. The width of the seat and handlebars is 25 inches. The release handle is 4 inches, and the front overhang is 2 inches. This product adds 2.5 inches to the toilet's height, making it compliant with the Americans with Disabilities Act (ADA) guidelines for accessible toilet seat height (17-19 inches). The Toilet Lift Assist weighs 50 pounds and lifts up to 80 percent of the user’s weight. The function of the device is to assist individuals with limited mobility or physical disabilities to safely and comfortably use the toilet. It is designed to mount directly onto the toilet to raise and lower the user, providing greater accessibility and independence. The high priced device from SedMed is marketed and sold to healthcare facilities and home users via medical device and equipment distributors and sellers. It can also be purchased directly from SedMed’s website. In your submission you requested consideration of a classification under subheading 9817.00.96, Harmonized Tariff Schedule of the United States (HTSUS), which covers: “[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.60, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped .” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection (CBP): (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. In HQ H055815 dated May 26, 2010, CBP found it unlikely that similar toilets that measure 17 inches from the floor to the top of the bowl rim would be acquired other than for the benefit or use of a handicapped individual who is likely to benefit when transferring from the wheelchair to the toilet and determined that although the toilet bowls/toilets are sold by a company that markets products to the general public, they were specifically advertised as ADA compliant. In HQ H246652 dated May 6, 2015, CBP states that a “product’s compliance with the ADA has been an important consideration in CBP’s determination under this factor.” In NY 865148 dated August 8, 1991, the Water-Powered Bath Lift Chair was designed for and would be used principally by persons suffering from a permanent or chronic impairment which substantially limited their ability to use regular toilet or bathing facilities. CBP granted duty free treatment under subheading 9817.00.96, HTSUS. In HQ 556449, dated May 5, 1992, the toilet seat raisers were designed for individuals with diminished mobility in hips and knees. CBP afforded them under subheading 9817.00.96, HTSUS. Based on the information provided and the precedents, it is the opinion of this office that SedMed’s Toilet Lift Assist qualifies for duty-free treatment under subheading 9817.00.96, HTSUS. The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) James Forkan Acting Director National Commodity Specialist Division

set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not 

conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. 
Sincerely,
 (for) James Forkan Acting Director National Commodity Specialist Division